Cleared Special

K223436 - Artix AX

K223436 is the FDA 510(k) clearance for Artix AX by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 108-day FDA review.

K223436 · Inari Medical · Cardiovascular device
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Mar 2023
Decision
108d
Days
Class 2
Risk

K223436 is an FDA 510(k) clearance for the Artix AX. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on March 2, 2023 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inari Medical devices

Submission Details

510(k) Number K223436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date March 02, 2023
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K223436.
InThrill Thrombectomy System
K223613 · Inari Medical, Inc. · Mar 2023
RevCore™ Thrombectomy Catheter.
K223609 · Inari Medical, Inc. · Mar 2023
Protrieve Sheath
K230331 · Inari Medical, Inc. · Mar 2023
Symphony Thrombectomy System
K223216 · Truvic Medical, Inc. · Feb 2023
Excipio LV Thrombectomy Device
K223897 · Contego Medical, Inc. · Feb 2023
Cobra Catheter System
K223891 · Endovascular Engineering · Feb 2023